A Study of the Toyota Production System: From an Industrial by Shigeo Shingo, Andrew P. Dillon

By Shigeo Shingo, Andrew P. Dillon

Here's Dr. Shingo's vintage business engineering motive for the concern of process-based over operational advancements for production. He explains the elemental mechanisms of the Toyota construction procedure in a realistic and easy approach that you should practice them on your personal plant. This publication clarifies the basic ideas of JIT together with leveling, average paintings tactics, multi-machine dealing with, and extra.

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Limits should be established on the basis of historical operating data. Labeling reconciliation is waived for either cut or roll labeling if a 100% examination for correct labeling is performed. (d) All excess labeling bearing a lot or control number must be destroyed. (e) Returned labeling should be maintained and stored in a manner to prevent mix-ups. (f) Written procedures should describe the control procedures used for the issuance of labeling. 3. There must be written procedures designed to assure that correct labels, labeling, and packaging materials are used.

In the case of certain OTC drug products lacking expiration dating because they meet the criteria for exemption, such written records must be maintained for three years after distribution of the drug product. (i) The written record must include the following information where known: the name and strength of the drug product, lot number, name of complainant, nature or complaint, and reply to the complainant. (ii) Where an investigation is conducted, the written record must include the findings of the investigation and follow-up.

Ii) The reasons that the drug product’s compliance with the tamper-evident packaging and labeling requirements is unnecessary or cannot be achieved. (iii) A description of alternative steps that are available or that the petitioner has already taken to reduce the likelihood that the product or drug class will be the subject of malicious adulteration. (iv) Other information justifying an exemption. Holders of approved new drug applications for OTC drug products are required to provide the FDA with notification of changes in packaging and labeling to comply with the requirements of this section.

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